AU2021238951A1 - High concentration anti-Aß protofibril antibody formulations and methods of use thereof - Google Patents

High concentration anti-Aß protofibril antibody formulations and methods of use thereof Download PDF

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Publication number
AU2021238951A1
AU2021238951A1 AU2021238951A AU2021238951A AU2021238951A1 AU 2021238951 A1 AU2021238951 A1 AU 2021238951A1 AU 2021238951 A AU2021238951 A AU 2021238951A AU 2021238951 A AU2021238951 A AU 2021238951A AU 2021238951 A1 AU2021238951 A1 AU 2021238951A1
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AU
Australia
Prior art keywords
pharmaceutical formulation
arginine
concentration
fragment
seq
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
AU2021238951A
Other languages
English (en)
Inventor
Yung Yueh HSU
Anjali Joshi
Hirokazu Kito
Takahiro Ozawa
Takahisa Sakaguchi
Naomi SAKURAMOTO
Pierre SOUILLAC
Nobuo Yoshida
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eisai R&D Management Co Ltd
Original Assignee
Eisai R&D Management Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Eisai R&D Management Co Ltd filed Critical Eisai R&D Management Co Ltd
Publication of AU2021238951A1 publication Critical patent/AU2021238951A1/en
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/133—Amines having hydroxy groups, e.g. sphingosine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Dermatology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Cosmetics (AREA)
  • Peptides Or Proteins (AREA)
AU2021238951A 2020-03-20 2021-03-19 High concentration anti-Aß protofibril antibody formulations and methods of use thereof Pending AU2021238951A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202062992746P 2020-03-20 2020-03-20
US62/992,746 2020-03-20
US202063027263P 2020-05-19 2020-05-19
US63/027,263 2020-05-19
PCT/IB2021/000155 WO2021186245A1 (en) 2020-03-20 2021-03-19 HIGH CONCENTRATION ANTI-Aß PROTOFIBRIL ANTIBODY FORMULATIONS AND METHODS OF USE THEREOF

Publications (1)

Publication Number Publication Date
AU2021238951A1 true AU2021238951A1 (en) 2022-10-20

Family

ID=75746958

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2021238951A Pending AU2021238951A1 (en) 2020-03-20 2021-03-19 High concentration anti-Aß protofibril antibody formulations and methods of use thereof

Country Status (14)

Country Link
US (1) US20230183328A1 (es)
EP (2) EP4252777A3 (es)
JP (1) JP2023518066A (es)
KR (1) KR20220156534A (es)
CN (1) CN115315251A (es)
AU (1) AU2021238951A1 (es)
BR (1) BR112022018766A2 (es)
CA (1) CA3174778A1 (es)
CL (1) CL2022002517A1 (es)
CO (1) CO2022012916A2 (es)
IL (1) IL295383A (es)
MX (1) MX2022011101A (es)
TW (1) TW202200201A (es)
WO (1) WO2021186245A1 (es)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MX2023000949A (es) 2020-07-23 2023-02-22 Othair Prothena Ltd Anticuerpos anti-beta-amiloide (abeta).
WO2023283650A1 (en) 2021-07-09 2023-01-12 Eisai R&D Management Co., Ltd. Biomarkers for alzheimer's disease treatment
TW202339794A (zh) 2022-02-02 2023-10-16 日商衛材R&D企管股份有限公司 使用ｐ—ｔａｕ１８１水平之治療方法
WO2024118665A1 (en) 2022-11-28 2024-06-06 Eisai R&D Management Co., Ltd. Methods of treatment using a tau pet level

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112805031A (zh) * 2018-07-24 2021-05-14 卫材R&D管理有限公司 阿尔茨海默病的治疗及预防方法

Also Published As

Publication number Publication date
TW202200201A (zh) 2022-01-01
CL2022002517A1 (es) 2023-03-24
EP4252777A3 (en) 2024-01-24
JP2023518066A (ja) 2023-04-27
KR20220156534A (ko) 2022-11-25
CO2022012916A2 (es) 2022-09-20
MX2022011101A (es) 2022-10-03
EP4252777A9 (en) 2024-03-06
BR112022018766A2 (pt) 2022-11-01
CA3174778A1 (en) 2021-09-23
IL295383A (en) 2022-10-01
CN115315251A (zh) 2022-11-08
US20230183328A1 (en) 2023-06-15
EP4252777A2 (en) 2023-10-04
WO2021186245A1 (en) 2021-09-23
EP4121007A1 (en) 2023-01-25

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